HR+ metastatic breast cancer: palbociclib+exemestane+leuprolide better than capecitabine

  • The Lancet Oncology

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Palbociclib plus endocrine therapy (ET) with exemestane plus ovarian function suppression with gonadotropin-releasing hormone agonist (leuprolide) extends survival by 6 months relative to capecitabine chemotherapy alone in premenopausal hormone receptor (HR)-positive metastatic breast cancer (mBCa).

Why this matters

  • Although clinical guidelines recommend endocrine therapy as the top treatment option, capecitabine is increasingly used in real-world patients with premenopausal or menopausal mBCa.

Study design

  • Korean phase 2 multicenter randomized controlled trial (n=178) of palbociclib (125 mg/day for 21 days every 4 weeks)+exemestane (25 mg/day for 28 days)+leuprolide (3.75 mg subcutaneously every 4 weeks) vs capecitabine (1250 mg/m2 twice daily for 2 weeks every 3 weeks).
  • Primary outcome was PFS.
  • Funding: Pfizer; other industry sponsors.

Key results

  • Median follow-up was 17 months (interquartile range, 9-22 months).
  • Combination therapy group's median PFS was 20.1 months (95% CI, 14.2-21.8 months) vs 14.4 months (95% CI, 12.1-17.0 months) in the chemotherapy group (HR, 0.659; 95% CI, 0.437-0.994).
  • Combination therapy had higher rates of treatment-related grade 3 or worse neutropenia (75% vs 16% in the chemo group), but lower rates of treatment-related serious adverse events (2% vs 17%, respectively).

Limitations

  • Open-label design.

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